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HOECHST/BIOVAIL ONCE-DAILY DILTIAZEM NDA APPROVAL DELAYED UNTIL MAY 1996

Executive Summary

HOECHST/BIOVAIL ONCE-DAILY DILTIAZEM NDA APPROVAL DELAYED UNTIL MAY 1996 by Marion Merrell Dow's manipulation of 505(b) regulations, Biovail alleges in an antitrust suit filed Oct. 19 in San Juan, Puerto Rico federal court. Biovail notes that because MMD filed a patent infringement suit, Hoechst's NDA cannot be approved by FDA until 30 months after MMD's receipt of the 505(b) notice, or May 1996, unless the federal court orders otherwise. MMD's patent suit is part of a "scheme to manipulate the administrative regulations to their benefit...impairing [Biovail's] ability to compete in the sustained-release diltiazem market," Biovail charges.

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